Real World Evidence & Late Phase

Positioning your product to a successful market entry.

Real World Evidence and Late Phase activities are key to understand the full potential of a medicine or a new therapy. The generation and collection of quality data and reporting creates a possibility of integrated analysis, which leads to cost-efficient decisions and leverages the capabilities of the late phase landscape.

In this scenario, each project is unique given its design, deliverables and regions. Specific requirements, different regulatory agencies, variations of processes for submission and different health economics perspectives need to be taken into consideration. A team of local experts in these areas is crucial for regulatory and scientific success.

At Eurotrials, we have a unique dedicated team to Real World Evidence & Late Phase studies, both for pharmaceutical products and medical devices. For over 20 years our team have been conducting studies for phases IIIb/IV, such as Registries, PAES, PASS, Population and Disease Characterization and Health Economics and Outcomes Research studies, among others.

Our operations has a full-service approach for post-approval activities, for interventional or non-interventional studies, building the right strategy for your product in order to generate the data and the evidence you need to achieve your scientific and marketing goals. From statistics and medical writing to monitoring and project management, Eurotrials helps you to get the answers you need for your product market access. With a data-based decision making approach, we answer economics questions in observational studies to lead your product to the maximum return.

Our solutions:

Phase IIIb/IV clinical trials

Compassionate Use & Expanded Access

Epidemiologic studies

Health Economics & Outcomes Research (HEOR)

Market Access & Reimbursement Strategy

Post-Authorization safety studies (PASS)

Post-Authorization efficacy studies (PAES)

Registries

Prospective & Retrospective Observational Studies

Pharmacovigilance

Biostatistics

Data Management

Associations:

Eurotrials is engaged to various associations for the development of the scientific community, such as The European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP), and the International Society for Pharmacoeconomics and Outcomes Research (ISPOR).

There is an increasing need for the collection and analysis of real world and clinical evidence, in different formats and sources, to allow the Pharmaceutical and Medical Devices Industries to answer questions and needs from different stakeholders.